This invention relates to surgical accessories and, more particularly, to a novel device comprising a hollow tubular member that can be inserted into the common bile duct of a patient during surgical procedure to perform plural beneficial functions.
The initial function performed by the novel device of the present invention is to provide, through its interior, a conduit for drainage of bile from inside the common bile duct to a location outside the body wall of the patient as is necessary during the healing process. Subsequently, however, as the healing process progresses, the novel device of the present invention performs the additional function, with its exterior, of promoting the growth of a fistulous tract between the outside of the body wall of the patient and the inside of the duct through which an instrument, such as a steerable basket catheter and the like, that has been non-surgically inserted into the duct via the interior of the tubular member for removal of an object, such as a retained stone and the like, contained therein, can be non-surgically withdrawn together with the object and the tubular member itself to a location outside of the body wall of the patient.
Once the novel device of the present invention has been withdrawn from the patient, it also provides, through the fistulous tract that has grown around the exterior of its stem, a passageway through which the aforenoted instrument can, if necessary, be non-surgically reinserted into the duct to non-surgically remove additional objects, such as additional retained stones and the like, from the duct to a location outside the body wall of the patient. And, that same fistulous tract can also provide a passageway through which yet another instrument, such as a flexible fiberoptic endoscope and the like, can be non-surgically inserted into the duct to inspect the same and, if desired, to remove biopsy tissue from the duct to a location outside the patient.
The novel device that is provided by the present invention is somewhat similar structurally to the conventional-type flexible surgical T tube drain, such as that which is shown and described in detail in U.S. Pat. No. 3,835,863, in that it also comprises a hollow tubular member having the shape of a "T", with the "T" including a crossbar that can be flexed and inserted into the common bile duct through an opening that has been surgically made through the duct wall and a stem which has its junction with the crossbar constructed such that the distal end of the stem which extends through the duct opening can be extended outwardly through an incision that has been surgically made through the body wall of the patient.
As set forth in U.S. Pat. No. 3,835,863, the aforenoted conventional-type flexible surgical T tube device can, of course, function, initially, to provide, through its interior, a conduit for drainage of bile from inside the common bile duct to a location outside of the body wall of the patient as is necessary during the healing process. And, as also has been described in recent publications, such as that by the co-inventor of the present device, Dr. Joseph G. Whelan, Jr. (Non-Operative Removal of Retained Biliary Tract Stones: Combined Percutaneous Extraction and Heparin Flushing Therapy), which appeared in the July, 1974 edition of The Journal of the Kentucky Medical Association, and another by Dr. Joseph A. Caprini et al (Nonoperative Extraction of Retained Common Duct Stones), which appeared in the April, 1976 edition of Arch Surg, such a conventional-type T tube drain or modifications thereof can also perform, as the healing process progresses, the additional function, with its exterior, of promoting the growth of a fistulous tract between the outside of the body wall of the patient and the inside of the duct through which, following removal of the conventional-type T tube drain from the patient, an instrument, such as a steerable basket catheter, can be non-surgically inserted into the duct for the non-surgical removal of objects, such as retained stones and the like, contained therein to a location outside the body wall of the patient.
As further described in the aforenoted U.S. Patent and publications, the inside and outside diametric dimensions, respectively, of both the crossbar and the stem of such a conventional-type T tube drain are the same, with, consequently, the outside diametric dimension of any instrument which can be passed through the interior of the stem, therefore, being limited to a size slightly less than the smallest inside diametric dimension of the stem and the outside diametric dimension of any object that can be non-surgically removed through the fistulous tract being limited to a dimension that is less than the smallest outside diametric dimension of the stem, which determines the smallest inside diametric dimension of the fistulous tract that is grown around it.
It is to be especially noted that attempts, following the withdrawal of such a conventional-type T tube drain from the patient, to non-surgically remove an object, such as a retained stone and the like, from the duct through the fistulous tract that has grown around the exterior of the stem of such a conventional-type T tube drain have frequently led to complications requiring emergency surgery involving re-opening of the incision through the body wall of the patient, when the largest combined outside diametric dimension of the object and the removing instrument exceeded the smallest inside diametric dimension of the fistulous tract thus grown.
As still further described in the aforenoted publications, previous efforts have also been made to enlarge the inside diametric dimension of the fistulous tract by sheathing the exterior of the stem of such a conventional-type T tube drain with a piece of tubing that has an inside diametric dimension that is similar to the outside diametric dimension of the stem and, of course, a greater outside diametric dimension, to, thus, promote the growth around the exterior of the sheathing tube piece of a fistulous tract having an enlarged inside diametric dimension when compared with that produced by the unsheathed stem, which, hence, would, in turn, permit the non-surgical withdrawal through that enlarged fistulous tract of objects having an enlarged outside diametric dimension.
While some success has been obtained in employing the just-noted practice of sheathing the stem of such a conventional-type T tube drain to promote the growth of a fistulous tract having an enlarged inside diametric dimension, there have, on the other hand, been frequent failures and other complications, typically caused by outward axial slippage of the sheath with respect to the stem in a direction away from the point at which the stem extends outwardly from the opening through the duct wall. Such slippage has, of course, produced a "bottleneck" section within the interior of the fistulous tract that has an inside diametric dimension that is substantially equal to the outside diametric dimension of the unsheathed stem, which defeats the just-described purpose of the sheathing practice. And, additional problems have been encountered with this sheathing practice, in the form of stagnation of body secretions between the surrounding sheath and the conventional-type T tube drain stem, which, in turn, can be undesirably introduced into the duct or body cavity of a patient as pus or infection, should the fistulous tract be ruptured following removal of the drain tube. Furthermore, the just-described sheathing practice does nothing whatsoever to provide the interior of the stem of the conventional-type T tube drain with any enlarged inside diametric dimension, which, in turn, would permit the insertion therethrough and into the duct of instruments having enlarged outside diametric dimensions.
However, in particular accordance with the present invention, the novel device that is provided thereby has a most-important structural difference from the aforenoted conventional-type T tube drain, in that it is constructed such that its stem has, along its entirety, both inside and outside diametric dimensions which are, respectively, greater than the inside and outside diametric dimension of its crossbar. Thus, with this just-noted novel structure, the device of the present invention provides, with the greater inside diametric dimension which extends along the entirety of the interior of its stem, a wider conduit for non-surgical insertion from a location outside of the body wall of the patient of instruments having an enlarged outside diametric dimension into the duct while, at the same time, also promoting, with the greater outside diametric dimension which also extends along the entirety of the exterior of its stem, the growth of a "bottleneck-free" fistulous tract through which objects having an enlarged outside diametric dimension can be non-surgically withdrawn from the duct to a location outside of the body wall of the patient.
Once the novel device of the present invention has been withdrawn from the patient, it also provides, through the fistulous tract that has grown around the exterior of its stem, a passageway through which the aforenoted instrument can, if necessary, be non-surgically reinserted into the duct to non-surgically remove additional objects, such as additional retained stones and the like, from the duct to a location outside the body wall of the patient. And, that same fistulous tract can also provide a passageway through which yet another instrument, such as a flexible fiberoptic endoscope and the like, can be non-surgically inserted into the duct to inspect the same and, if desired, to remove biopsy tissue from the duct to a location outside the patient.